THE WAY AHEAD

To advance fundamental knowledge in the field of molecular cell biology and to apply such knowledgemolecular cell biology, and to apply such knowledge

to the understanding, and the prevention of and treatment of human diseases

Advances of Science and Technology and the Consequence of Biological Risksthe Consequence of Biological Risks

Natural disease Deliberate Unintended Accident VandalisNegligencNatural disease Deliberate Unintended

conseq ences Accidents Vandalism, Negligencedisease outbreak use of

BWconsequences

Accidents m,

sabotage

Negligence

WHO BWC

disease outbreak use of

BWconsequences Accidents sabotageNegligence

WHO BWC

Many actors should be involves:Law enforcement, science and technology, education and training, public health, agriculture custom and many moreagriculture, custom and many more

Indonesia’s Experience on Reducing Biological RisksReducing Biological Risks

Biosafety biosecurity prevention measuresRisk assessmentsBiosafety laboratories infrastructures for dangerous pathogens

Systems to detect diagnose trackSystems to detect, diagnose, track outbreaks and the origins of the outbreak of highly infectious diseasesg yEmergency response systems for control and containment of infectious disease eventsCapacity building activities to support public health and security goalshealth and security goals

Indonesia – A Rapidly Developing Country with Serious Problems in Infectious Diseasew Se ous ob e s ec ous se se

Malaria:15 million malaria cases and 42 000 deaths every year (2005)– 15 million malaria cases and 42,000 deaths every year (2005)

– Highest case number and fatality rate in the world

Tuberculosis:– ranked third in TB burden following India and China– TB is third of major causes of mortality in Indonesia– WHO estimate, Indonesia has 269 TB cases/100,000 populations

Dengue: – Most important viral borne disease in Indonesia– Outbreak in 2004: 78,690 cases with 954 deaths (CFR- 1.2%)( )– In 2007: 123,174 cases with 1,251 deaths

Hepatitis B:– 10% (3 4-20 3%) of population are HBV carriers– 10% (3.4-20.3%) of population are HBV carriers– Moderate-to-high endemic (WHO)

Avian Influenza:– June 2005-June 2009: 262 positive cases; 115 deaths, CFR: 80%– Highest case number and fatality rate in the world

National Actions to Promote Capacity Building in C t i t Di S ill D t ti dContainment, Disease Surveillance, Detection and Diagnosis of Infectious Disease

Building a safe, secure and sustainability capacityBest practices on biological safety and securityBest practices on biological safety and securityBuilding capacity to detect, diagnose and track outbreaks of highly infectious diseasesoutbreaks of highly infectious diseasesEnhancing cooperation

Jakarta SurabayaJakartaEIJKMAN

NIHRDUI

TDC-UNAIR

BogorBALITVET

Institutions working on Avian Influenza and BSL3 facilities

Why Need for a BSL3 Facility?

RESEARCH IS AN ESSENTIAL COMPONENT OFRESEARCH IS AN ESSENTIAL COMPONENT OF RESPONSE TO EMERGING INFECTIOUS DISEASES

Role in national response to Emerging Infectious Disease• To provide scientific and technological support to the p g pp

national diagnostic laboratory network, including capacity building

• As the leading research laboratory in particular inAs the leading research laboratory, in particular in genomic research (viral as well as host) and pathology

• As the major back up diagnostic facility in emergency situation such as in pandemic responsesituation, such as in pandemic response

Prepare for future emerging infectious disease threat e.g recent experience of NOT being able to respondrecent experience of NOT being able to respond scientifically to threat of SARS

Building a BSL3 Facility at EijkmanEijkman Institute

• Arcitecture has to fit with the historical colonial buildingg• For handling pathogenic microorganisms – bacteria, viruses• No animal work carried out

Under very closed supervision – invite DNV from the very beginning to review plans and proposed measures to ensure they are adequate and will result in a facility which is designed and constructed in line with internationally recognised good practice for BSL-3 laboratories in relationrecognised good practice for BSL-3 laboratories in relation to HSE management and containment principles..’

Capacity Building in Containment –BSL3 Facilities in Indonesia

JakartaEIJKMAN

SurabayaTDC-UNAIR

NIHRDUI

BogorBALITVETBALITVET

Three facilities for human samples and two for animal works

Planning vision: What is the long term plan to ensure gsustainability?What support (financial, collaborative, others) will be needed for? )

Capacity Building in Containment –Challenges in Best PracticesChallenges in Best Practices

G d f ili i d d ffi i if lGood facilities and procedures are not sufficient if personnel are not adequately trained and do not clearly understand their roles and responsibility

Laboratory biosecurity training, complementary t bi f t t i i i id d t ti

p y

to biosafety training is provided - protection, assurance and continuity of operations

Should not be a one-time event – offered regularly and taken currently. To refresh g y ymemories and to learn about new developments and advances in different areas

Management System is the Key for a Good Laboratory Practice in Biosafety

History of running containment facilities?Management system had to be started from basics• Policies• Biosafety manual• Biosafety manual• SOPs• Risk assessments• Etc.New personnel• Laboratory manager• Laboratory manager• Staff• MaintenanceSome documentation supplied from other institutes and support to get program startedNeed own system which fits individual institute and cultureNeed own system which fits individual institute and culture

Capacity Building in Promoting and Implementing Biosafety and Biosecurity Management –

Norway Indonesia Initiative

More than 70 representatives from 17 countriesMore than 70 representatives from 17 countriesContributions by the WHO, APBSA and academia

Need to enhance capabilities in addressing challenges such as emerging and re-emerging diseasesCapabilities must be adapted to local needs -Capabilities must be adapted to local needs complexities involved in setting up new laboratories, many challenges associated

ith t ti i i t dwith construction, on-going maintenance and running costsIncreased co-operation between countries –pmake a use of existing capabilities and resources

Summary of Regional Seminar on Promoting and Implementing Biosafety and Biosecurity Management, Jakarta, Juni 2008

Adequate systems to address biosafety and biosecurity are critical in overcoming these challenges - involve physical structures strong commitmentphysical structures, strong commitment by senior management, development of safety and security procedures andof safety and security procedures and trainingIt was affirmed that countries in the

region should learn from each other’s experiences

Experience from the Eijkman Institutei f ti l lis of particular relevance

Laboratory Capacity and Capability Building to Overcome Deficiencies in Management SystemOvercome Deficiencies in Management System

E t bli hi ff ti b t tiEstablishing an effective, best practice management system, incorporating safety and security management process and associated proceduresDevising necessary document templatesDeveloping the training programs and p g g p gmaterialDeveloping a generic model of the system which can be applied in other Institutes inwhich can be applied in other Institutes in Indonesia and elsewhereEnhancing communication around bioriskmanagement and capacity building at allmanagement and capacity building at all levels within SEA and beyondConcept and practices based on CWA 15793 2008 L b t Bi i k15793: 2008 Laboratory BioriskManagement Standard Supported by the Norwegian Ministry

of Foreign Affairs

Manpower Development Through Training, Specific Workshops and SeminarsSpecific Workshops and Seminars

2006 Laboratory Biosecurity and Biosafety for BSL3 Laboratories, Bogor; APBA Biosafety Management Course, Singapore, Julyg ; y g , g p , y

2007 Lab for the 21st Century, High performance, Low Energy Design Course, Scottsdale, April; Safe BSL3 Work Practices and Procedures, Scottsdale; ABSA 50th Conference and Biological Safety Course, October

2008 d2008 3rd APBA Aerobiology Workshop and Conference, Bangkok; 3rd Annual Conference SEA Influenza Clinical Research Network, Bali; Regional Seminar on Promoting and I l ti Bi f t d Bi it M t J k tImplementing Biosafety and Biosecurity Management, Jakarta, June; Laboratory Biorisk Management System Workshop, Jakarta, Augustt2009 Advanced Topics in Managing BSL3 Laboratories, CDC Atlanta, January; BSL3 Science and Safety Training Course at Emory University Atlanta March; 4th APBA Conference andEmory University, Atlanta, March; 4th APBA Conference and CWA15793 Biosafety Standard Training, Implementation and Auditing Workshop and, Manila, April

Building Capacity in Detection and Diagnosis of Infectious DiseasesDiagnosis of Infectious Diseases

Development of diagnostic tests (AI)

Diagnosed by virus isolation – hemaglutinating activity indicates the presence of influenza virusindicates the presence of influenza virusReverse Transcriptation-PCR assay for molecular identification

C fPositive test by RT-PCR should be confirmed by the second Institution RT-PCR and antigen testing carried out in BSL2RT PCR and antigen testing carried out in BSL2

Tracking outbreaks

BSL3 laboratory conditions are required for HPAI viruses culture - detection of viral sequence changes q g(infection with other subtypes have been associated with outbreaks in other species)

The Role of Science and Technology in Health Security – Preparedness for PandemicSecurity Preparedness for Pandemic

Risk AssessmentsRisk AssessmentsEpidemiology:

• Grouping of H5N1:Virological clades or p g gsubclades - H5N1 of Indonesian isolates clustered together – no new strain

• Surveilance tracing sources of infection• Surveilance - tracing sources of infectionCharacteristics of Virus

• Alteration of interaction with host receptors p- Pandemic need changing in specificity of avian type receptor (α 2,3) into human-type (α2,6) - showed the presence of avian-type(α2,6) showed the presence of avian type receptor

• Change of virulence • Drug resistance –no sign

National Capacity in Emerging Infectious Diseases Diagnostic and Laboratory NetworkDiagnostic and Laboratory Network

Central Laboratory

• Eijkman Institute• NIHRD-MOH

FKUIFKUSU

MOH B d

MOH S’baya

FKUSU

UNHASFKUNDIP FK UNUD

MOH Plembang

Bandung

Front line Laboratories:

BTKLHospital LaboratoryHospital LaboratoryDistrict Laboratory

44 Reference laboratories for emerging infectious diseases were d l d t i ti l it i d t ti d di tideveloped to increase national capacity in detection and diagnostic.Quality control and sustainability of the operation is very important!

Indonesia: Challenges in Promoting Capacity Building in Diagnosis and Detection p y g gof Infectious Diseases

A maritime continentHave 700 languages – population very diverseHave 700 languages population very diverseA crossroad of ancient migration – influenced the genetic background of host and pathogen H i i D M l i T b l i h diHepatitis, Dengue, Malaria, Tuberculosis show disease complexity

Dengue Situation in Indonesia – Management of Disease is not Simple, Need a Strong Disease S ill d F d t l R h

250000

2007: 157 442 cases with 1 446DENGUE TREND IN INDONESIA AND SOUTHEAST ASIA 1985-2006

Surveillance and Fundamental Research

0

50000

100000

150000

200000

C A

S E

2007: 157,442 cases with 1,446 deaths (WHO SEARO)Reported dengue cases is rising but case

0

1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

Indonesia South-east Asia Region fatality rate is maintained below 1%

DENV Serotype Distribution in Indonesia DENV Serotype Distribution in Indonesia Four antigenically

Palembang 1998

distinct serotypes: nfection with one serotype does not

id t ti

Merauke 2001

Jakarta 2004

Bandung 2002Yogyakarta 1996 ?

Jayapura 1994

provide protection to the other three

Corwin 2001; Suwandono 2006; Porter 2005; Graham 1999; Richards 1997; Sukri 2003

Merauke 2001Bandung 2002 ?Makassar

Serotype Legend:

4 13 2

Preparedness for New Emerging Infectious Diseases

FROM BENCH TO BEDSIDE - the capability to respond to a new emerging infectious diseases – i.e. designing new detection method for A/H1N1 on HA, NA and PB2 genes based on 133 sequences deposited at GISAID

Adopt new detection protocol (CDC and SEARN – Oxford)

M f Di i Si l N d S DiManagement of Disease is not Simple, Need a Strong Disease Surveillance and Fundamental Research

Capacity Building Through Education and Awareness on Code of Conduct on Biosecurityy

The Indonesian Academy of Science (AIPI) with its partner the Royal Netherlands Academy of Arts and Sciences (KNAW) toRoyal Netherlands Academy of Arts and Sciences (KNAW) - to produce, promote and disseminate Code of Conduct on Biosecurity in Indonesia.y

KNAW has produced its Code of Conduct on 2007 as required by BTWC which was ratified on 1972 and endorsed by

P i i l d d b i l di h I d i A d f

required by BTWC which was ratified on 1972 and endorsed by the Inter Academy Panel (68 national academies of science )

Principles endorsed by including the Indonesian Academy of Sciences, working through Inter Academy Panel (IAP):

raising awareness, research and publication policy, accountability and oversight, internal and external communication, accessibility and shipment and transport.

Enhancing Cooperation

ARF Biological Threat Reduction Forum, Manila, 10-11 June 2009, attended by 60 participants from 22 countries and agencies such as WHO, FAO, INTERPOL and UN Office of Disarmament Affairs

Networking with interagency counterparts, personal in health, academia, law enforcement, defense and multiple stakeholders includingdefense and multiple stakeholders including industry, medical, professional organizations and the media.

Regional cooperation is necessary not only in the field of biosafety and biosecurity but also inthe field of biosafety and biosecurity but also in infectious diseases research and surveillance -APBA, ABSA, SEA Network of Influenza and many other associations

THE WAY AHEADRaising awareness of biologically threats globally – BWC, BTR, Dual Use, Code of Conduct, ,Strengthening laboratory biosafety and biosecurity to protect laboratory capacity and safely combat infectious diseases Training SOPdiseases – Training, SOPExpanding the use of safe and modern diagnostics –National capacity building in fundamental and translational y gresearchParticipation in infectious disease surveillance networks –Sharing quality data/informationSharing quality data/informationEnsure the sustainability of maintenance and managementMaximize existing resources and facilities to enhance effectiveness and efficienciesNew vaccines, antibiotics and a basic understanding of pathogenic nature of diseases are critical for health securitypathogenic nature of diseases are critical for health security - invest in basic science and fundamental research

T th W CTogether, We Can

Th k d ti f I d iThank you and greetings from IndonesiaHerawati Sudoyo MD PhD, Eijkman Institute for Molecular Biology, Indonesia